Tyrosine Kinase Inhibitors in Metastastic Adenoid Cystic Carcinoma

NCT04974866 | Recruiting Phase 2

• 1 other identifier: QDCH2021-07-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

There is no clinical study on epidermal growth factor receptor tyrosine kinase inhibitors has been systematically conducted in adenoid cystic carcinoma. This is a phase II study EGFR TKIs in adenoid cystic carcinoma to evaluate its efficacy in this disease.

Conditions

Carcinoma, Adenoid Cystic

Keywords

Neoplasms, Glandular and Epithelial; Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• progression free survival

  progression free survival

  10 months

Secondary Outcomes (1)

• overall survival

  2 years

Study Arms (1)

study drug

EXPERIMENTAL

EGFR TKIs

Drug: EGFR-TK Inhibitor

Interventions

EGFR-TK Inhibitor DRUG

epidermal growth factor receptor tyrosine kinase inhibitors

study drug

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed adenoid cystic carcinoma
• Local, locally-advanced or metastatic disease documented as having shown progression on a scan (CT, MRI, MIBI scan) taken 2 to 12 months prior to baseline compared to a previous scan taken at any time in the past. Progression must be documented according to RECIST criteria.
• Disease that is not amenable to surgery, radiation or combined modality therapy with curative intent and who is previously treated with chemotherapy or local treatment (e,g transarterial chemoembolization)
• Presence of at least one measurable target lesion for further evaluation according to RECIST criteria
• years or older
• ECOG performance status 0, 1, 2, 3
• Previous treatment with chemotherapy, loco-regional therapy (e.g chemoembolization) are permitted providing that toxicity has resolved to ≤grade 1 at study entry and that last treatment was at least 4 weeks prior to baseline assessment.
• Adequate organ function
• A patient with the willingness to comply with the study protocol during the study period and capable of complying with it
• A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages.

You may not qualify if:

• \. A patient with no measurable disease, or allergy to the EGFR TKIs 2. Prior chemotherapy, radiation therapy or surgery within 4 weeks prior to study entry except palliative radiotherapy to non-target lesions (within 2 weeks prior to study entry) 4. A patient with intestinal obstruction or impending obstruction, recent active upper GI bleeding 5. A pregnant or lactating patient 6. A patient of childbearing potential without being tested for pregnancy at baseline or with being tested for positive. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential) 7. A man or woman of childbearing potential who has no willingness to use a contraceptive measure during the study 9. A patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications.
• \. A patient with clinically significant heart disease (e.g. congestive heart failure, symptomatic coronary artery diseases, cardiac arrhythmia, etc) or myocardial infarction within past 12 months.
• \. Ongoing cardiac arrhythmia of grade ≥2, atrial fibrillation of any grade, or QTc interval\>450msec for males or \>470msec for female.
• \. A patient with interstitial pneumonia or diffuse symptomatic fibrosis of the lungs

Sponsors & Collaborators

• Qingdao Central Hospital: lead

Study Sites (1)

Qingdao central Hospital

Qingdao, Shandong, 266042, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic; Neoplasms, Glandular and Epithelial; Adenocarcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 23, 2021
• Study Start: July 1, 2021
• Primary Completion: July 31, 2024
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)